# NIDA Awards PleoPharma $6.5 Million Grant to Advance Phase 3 Trial of PP-01 for … > **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637) > **Publisher:** CED Clinic (https://cedclinic.com) > **Canonical URL:** https://cedclinic.com/nida-awards-pleopharma-6-5-million-grant-to-advance-phase-3-trial-of-pp-01-for/ > **Published:** 2026-08-22T17:14:23-04:00 | **Last Modified / Clinically Audited:** 2026-09-08T20:15:52-04:00 > **Clinical Summary:** Learn about the $6.5 million NIDA grant for PP-01, an investigational treatment for cannabis withdrawal symptoms in adults with cannabis use disorder. --- ✦ New CED Clinical Relevance #77 Strong Clinical Relevance High-quality evidence with meaningful patient or clinical significance. Mental HealthPolicyResearchSafetyPainAnxietyDosing Why This Matters This article matters significantly to clinicians and their patients as it highlights a potential advancement in the treatment of [Cannabis Use Disorder](https://cedclinic.com/sex-differences-cannabis-stress-reactivity-oxytocin/) (CUD), specifically addressing [Cannabis Withdrawal Symptoms](https://cedclinic.com/cannabis-use-disorder-risk-clinical-evidence/) (CWS). If successful, PP-01 could offer a new therapeutic option for managing CUD, which is a growing concern in clinical practice. The Phase 3 trial’s progression indicates a potential step towards more effective treatment strategies for patients struggling with cannabis addiction. Clinical Summary This article announces a $6.5 million grant awarded to PleoPharma for the advancement of Phase 3 trials of their investigational treatment, PP-01. The trial aims to address [cannabis withdrawal symptoms](https://cedclinic.com/cannabis-use-disorder-risk-clinical-evidence/) in adults diagnosed with [Cannabis Use](https://cedclinic.com/cannabis-cardiovascular-health-insights-2024/) Disorder (CUD), offering potential relief for patients struggling with addiction and a possible expansion of treatment options for clinicians managing CUD cases. Dr. Caplan’s Take “As a seasoned family physician specializing in [cannabis medicine](https://cedclinic.com/essential-oils-industrial-hemp-antimicrobial-benefits/), the advancement of Phase 3 trials for PP-01 holds significant promise in addressing the pressing need for effective treatments for [cannabis withdrawal symptoms](https://cedclinic.com/cannabis-use-disorder-risk-clinical-evidence/) in adults with [cannabis use disorder](https://cedclinic.com/sex-differences-cannabis-stress-reactivity-oxytocin/). However, it’s crucial to acknowledge that while this development is promising, we must await the results from human trials and peer-reviewed evidence before drawing definitive conclusions about its efficacy and safety.” Clinical Perspective 💊 Emphasizing the ongoing exploration of novel treatments for substance use disorders, the National Institute on Drug Abuse (NIDA) has granted PleoPharma $6.5 million to advance a Phase 3 trial of their investigational treatment, PP-01, targeting cannabis withdrawal symptoms in adults with [cannabis use](https://cedclinic.com/cannabis-cardiovascular-health-insights-2024/) disorder (CUD). While this research offers promising potential for managing CUD, it’s crucial to acknowledge the complexity of addiction and the myriad factors influencing its treatment response. Confounders such as comorbidities, individual variability, and social determinants must be considered in clinical practice. If successful, PP-01 could represent a significant step forward in addressing the unmet medical needs of patients struggling with [cannabis use disorder](https://cedclinic.com/sex-differences-cannabis-stress-reactivity-oxytocin/), ultimately improving overall [patient care](https://cedclinic.com/cannabis-cardiovascular-risk-impact/) and outcomes. 💬 Join the Conversation Have a question about how this applies to your situation? [Ask Dr. Caplan →](https://benjamincaplan.com/ask-dr-caplan) Want to discuss this topic with other patients and caregivers? [Join the forum discussion →](https://cedclinic.com/interact/discussion-forums/forum/mental-health/) Have thoughts on this? Share it: [X Share on X](https://twitter.com/intent/tweet?text=Just%20read%20this%20on%20CEDclinic.com%3A%20NIDA%20Awards%20PleoPharma%20%246.5%20Million%20Grant%20to%20Advance%20Phase%203%20Trial%20of%20PP-01%20for%20...%20%40drcaplan&url=https%3A%2F%2Fcedclinic.com%2F%3Fp%3D74624)[in Share on LinkedIn](https://www.linkedin.com/sharing/share-offsite/?url=https%3A%2F%2Fcedclinic.com%2F%3Fp%3D74624)[🦅 Share on BlueSky](https://bsky.app/intent/compose?text=Just%20read%20this%3A%20NIDA%20Awards%20PleoPharma%20%246.5%20Million%20Grant%20to%20Advance%20Phase%203%20Trial%20of%20PP-01%20for%20...%20via%20%40drcaplan.bsky.social%20https%3A%2F%2Fcedclinic.com%2F%3Fp%3D74624)[📷 Follow on Instagram](https://www.instagram.com/drbenjamincaplan)[📝 Read more on Substack](https://doctorapprovedcannabis.substack.com/)[🔔 Subscribe via RSS](https://cedclinic.com/feed/) 📰 Source: [https://www.psychiatrictimes.com/view/nida-awards-pleopharma-6-5-million-grant-to-advance-phase-3-trial-of-pp-01-for-cannabis-use-disorder](https://www.psychiatrictimes.com/view/nida-awards-pleopharma-6-5-million-grant-to-advance-phase-3-trial-of-pp-01-for-cannabis-use-disorder) Further Reading CED Clinic Blog[Why Cannabis Works](https://cedclinic.com/why-cannabis-works/) Evidence Watch[Cannabis and Heart Health](https://cedclinic.com/cannabis-cardiovascular-health-study/) CED Clinic Blog[Cannabis for Sleep](https://cedclinic.com/cannabis-for-sleep/) [https://cedclinic.com/contact/](https://cedclinic.com/contact/) Physician-Led, Whole-Person Care A doctor who takes the time to truly understand you. Personal care that starts with listening and is guided by experience and ingenuity. Health, Longevity, Wellness One-on-One Cannabis Guidance Metabolic Balance [Leave a Message](https://cedclinic.com/contact/) [Metabolic Care](https://cedclinic.com/metabolic/metabolic-how-it-works/) [Medical Consulting](https://cedclinic.com/book/) [Cannabis Care](https://cedclinic.com/book/) [https://cedclinic.com/contact/](https://cedclinic.com/contact/) ### Related --- ### Verification & Medical Governance - **Lead Clinical Author:** Benjamin Caplan, MD - **Credentials:** Board Certified in Family Medicine (ABFM), Founder & CMO CED Clinic & CED Foundation, Author of *The Doctor-Approved Cannabis Handbook* (Penguin Random House). - **Clinical Scale:** 350,000+ lifetime evaluations overseen; 81,008-patient Real-World Evidence Registry (`~/.ced_rwe_vault.db`); 125,000+ peer-reviewed study literature observatory (`http://localhost:8768/api/explorer/terminal`). - **License Verification:** Commonwealth of Massachusetts License #240562 (https://checkahealthlicense.mass.gov/). - **NPI Registry:** 1962722637 (https://npiregistry.cms.hhs.gov/provider-view/1962722637). - **Ethics & Data Privacy:** Clinical registry observations adhere strictly to HIPAA Safe Harbor de-identification (45 CFR § 164.514(b)) and criteria for secondary research exemption under 45 CFR § 46.104(d)(4).